Category Archives: Quality

22Feb/18
Infographics Top Section Square - 2 - 240 by 181

New Research: Driving a Culture of Quality Within the Medical Device Ecosystem

Axendia conducted a study focusing on the medical device induCulture of Quality Infographicstry’s ability to build a “Culture of Innovation and Quality.” The goals of this research were to identify and analyze trends, requirements and initiatives organizations are undertaking to proactively manage products and platforms across the product lifecycle.

In support of the research, we surveyed 110 medical device professionals representing 59 medical device manufacturers from 12 countries, and engaged in one-on-one interviews and group discussions with industry thought leaders.

The research resulted in an e-Book: Driving a Culture of Quality Within the Medical Device Manufacturing Ecosystem.  In it, we discuss the value, challenges and opportunities of transitioning medical device companies from the current regulatory and compliance focus – to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.  We also reveal how the Industry is prioritizing investments in technology in support of quality initiatives.

See the Infographic to learn more.

Read the e-Book.

14Feb/18
thinking

What is FDA Thinking? We Asked, They Answered!

An Interview with Francisco (Cisco) Vicenty – US FDA

By: Daniel R. Matlis, President

That is a question I often hear from industry executives around the globe.

To answer this question, I sat down with FDA’s Francisco Vicenty, for over an hour, to discuss a wide range of topics and gain an understanding of FDA’s current thinking on these topics. Cisco Vicenty is the Case for Quality Program Manager at FDA’s Office of Compliance, CDRH.

FDA-Axendia-Webinar

Driving a Culture of Quality in Industry

The overarching drive at FDA is enabling high levels of product excellence and innovation across industry and to provide patients with access to high quality, safe, and effective medical devices.  The agency wants to incentivize industry to adopt quality best practices; to adopt product quality excellence that drives improved patient outcomes.


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11Jan/18
2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as:

11Dec/17
Moped

Compliance vs Quality – India Edition

By Daniel R. Matlis

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

GroupThis visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry.  Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance.  In addition streamlined processes result in operational efficiencies and reduce waste.  Investing in improving product quality lowers costs and improves outcomes

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03Nov/17
CLOUD IMAGE

ComplianceQuest Offers Cloud Native Enterprise Quality Management Solutions

By: Daniel R. Matlis

Axendia was recently briefed by ComplianceQuest’s executive team.  The team, 80% of whom have deep experience in the Enterprise Quality Management Solutions (EQMS) market, has developed a cloud native EQMS built on the Salesforce platform.

ComplianceQuest was developed on the Salesforce cloud solution to provide a worry-free infrastructure platform that can be available anywhere, anytime. In addition, Salesforce provides a reliable, versatile infrastructure that can scale for all size companies. Another benefit of developing on the Salesforce platform is the ability to leverage advanced capabilities such as mobility, social media, artificial intelligence and machine learning and be ready for future technologies.Network_Navy_F

“ComplianceQuest provides a unique combination of niche experience, solutions and services across multiple industries with comprehensive capabilities in quality, safety and compliance throughout the supply chain,” said Nikki Willett, Chief Strategy Officer at ComplianceQuest. “Suitable for small companies and secure, scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate and use,” she added.

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